Cleared Traditional

K871208 - UNIPOLAR ENDOCARDIAL SCREW-IN LEAD

K871208 is the FDA 510(k) clearance for UNIPOLAR ENDOCARDIAL SCREW-IN LEAD by Pacesetter Systems. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K871208 · Pacesetter Systems · Cardiovascular device
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Jun 1987
Decision
72d
Days
Class 2
Risk

K871208 is an FDA 510(k) clearance for the UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pacesetter Systems devices

Submission Details

510(k) Number K871208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1987
Decision Date June 05, 1987
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K871208.
OLYMPUS ANGIOSCOPY SHEATH
K873100 · Olympus Corp. · Feb 1988
PULL-APART INTRODUCER (SHEATH)
K873727 · Quinton, Inc. · Oct 1987
OVAL PULL-APART SHEATH/DILATOR
K873394 · Quinton, Inc. · Sep 1987
PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK
K870374 · Daig Corp. · Mar 1987
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH
K864705 · Quinton, Inc. · Feb 1987
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K864352 · Quinton, Inc. · Jan 1987